Conventional Caudal BlockNCT04712370
Conventional Caudal Block, Ultrasound Guided Caudal Block and Ultrasound Guided Erector Spinae Block for Pediatric Hip Surgery
A study testing Conventional caudal block, Ultrasound-guided caudal block and Ultrasound guided erector spinae plane Block in people with Conventional Caudal Block and Ultrasound Guided Caudal Block, run by Tanta University at 1 site in Egypt.
Trial summary
This study will be conducted to compare the efficacy and safety of ultrasound guided erector spinae block , ultrasound guided caudal block and conventional caudal block for pain management after pediatric hip surgery. Read more about this study
- Who is it for?
- Ages 4 to 12 years
- Conditions the study is for
- Conventional Caudal Block, Ultrasound Guided Caudal Block, Ultrasound Guided Erector Spinae Block
- What is being tested?
- Conventional caudal block, Ultrasound-guided caudal block and Ultrasound guided erector spinae plane Block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- 1 siteEgypt
- Study dates
- 16 Jan 2021to 10 Sep 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Both sex
- ASA physical activity I, II
- Age 4-12 years
- Admitted for elective hip surgery.
Who cannot join
- Parents refusal
- Children with severe systemic disease
- ASA III or IV
- Children with previous neurological or spinal anomaly, coagulation disorders
- History of premature birth
- Infection at the block injection site
- History of allergy to local anesthetics
- Bilateral hip surgery.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Tanta University Hospitals
Tanta, ElGharbiaa, 31527
Eman Hamdy Abu-Shanab, +201005518097, eman.hamdy@med.tanta.edu.eg
About this study
Official title: Comparison of Conventional Caudal Block, Ultrasound Guided Caudal Block and Ultrasound Guided Erector Spinae Block for Pediatric Hip Surgery
This study will be conducted to compare the efficacy and safety of ultrasound guided erector spinae block , ultrasound guided caudal block and conventional caudal block for pain management after pediatric hip surgery.
- Conditions
- Conventional Caudal Block, Ultrasound Guided Caudal Block, Ultrasound Guided Erector Spinae Block, Pediatric Hip Surgery
- Being tested
- Conventional caudal block, Ultrasound-guided caudal block, Ultrasound guided erector spinae plane Block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional caudal blockProcedure or surgery
Patients of this group will receive (0.5ml/kg) (plain bupivacaine 0.25% injected in the caudal epidural space) by the conventional method (blind technique without ultrasound).
Ultrasound-guided caudal blockProcedure or surgery
Using ultrasound, patients of this group will receive (0.5ml/kg) (plain bupivacaine 0.25% injected in the caudal epidural space).
Ultrasound guided erector spinae plane BlockProcedure or surgery
Under ultrasound guidance, patients of this group will receive (0.5ml/kg) (plain bupivacaine 0.25% injected beneath the erector spinae muscle sheath) at the level of the transverse process of the second lumbar vertebrae(L2).
| Study group | Role | What they receive |
|---|---|---|
| Conventional caudal block | Active comparator | Patients of this group will receive the conventional method (blind technique without ultrasound) of caudal block Receives: Procedure: Conventional caudal block |
| Ultrasound-guided caudal block | Experimental | Patients of this group will receive caudal block using ultrasound. Receives: Procedure: Ultrasound-guided caudal block |
| Ultrasound guided erector spinae plane Block | Experimental | Patients of this group will receive ultrasound guided erector spinae plane Block at the level of the transverse process of the second lumbar vertebrae(L2) . Receives: Procedure: Ultrasound guided erector spinae plane Block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Degree of pain intensity
To evaluate the pain scores by (FLACC) scale. (FLACC) scale will be assessed after surgery over 24 hours where (0 = Relaxed and comfortable, 1-3 = Mild discomfort, 4-6 = Moderate pain ,7-10 = Severe discomfort /pain)
Measured: First 24 hours postoperative
Secondary outcomes (7)
Changes in mean arterial blood pressure
Mean arterial blood pressure will be recorded before block performance at T0, intraoperatively at 15 and 30 minutes, then every 30 min till the end of surgery and after surgery at T (0, 2, 4, 6, 12, 24 h).
Measured: Intraoperative and first 24 hours postoperative
Changes in heart rate
Heart rate will be recorded before block performance at T0, intraoperatively at 15 and 30 minutes, then every 30 min till the end of surgery and after surgery at T (0, 2, 4, 6, 12, 24 h).
Measured: Intraoperative and first 24 hours postoperative
Amount of Analgesic required in the first day after surgery
The total dose of intravenous (IV) acetaminophen 15 mg/kg if FLACC scores between 2 and 4 at the first 24 h after surgery, and total dose of tramadol 1 mg/kg (IV) in case of FLACC score > 4.
Measured: First 24 hours postoperative
Time to first rescue analgesic demand after surgery.
measured from the end of surgery till patient require analgesia.
Measured: First 24 hours postoperative
Success rate of block
a successful block is defined as absence of significant changes in heart rate following surgical induction. Heart rate increase is not>20% of the basal levels. If the increase is>20%, the block is accepted as unsuccessful.
Measured: Intraoperative duration
Duration of performing the block
Block performing time is defined as the period between the insertion of the needle and termination of local anesthetic administration
Measured: Intraoperative duration
Incidence of complications
Hypotension, bradycardia, postoperative nausea, vomiting, urinary retention, prolonged motor block, pruritus and local anesthetic systemic toxicity (LAST).
Measured: Intraoperative and first 24 hours postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2021
- Study start16 Jan 2021
- Primary completion1 Sep 2021 (estimated)
- Study completion10 Sep 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Conventional Caudal BlockStudies of the same condition, open and under way.
- More trials run by Tanta UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 105 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eman Hamdy Abu-Shanab, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04712370
- Sponsor's protocol ID
- 33143/05/19
- Status last verified
- Jan 2021
- First submitted
- 11 Jan 2021
- Last updated
- 20 Jan 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be available upon reasonable request
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Conventional Caudal Block, Ultrasound Guided Caudal Block and Ultrasound Guided Erector Spinae Block for Pediatric Hip Surgery
- ClinicalTrials.gov ID
- NCT04712370
- Acronym / sponsor ID
- 33143/05/19
- Conditions
- Conventional Caudal Block, Ultrasound Guided Caudal Block, Ultrasound Guided Erector Spinae Block, Pediatric Hip Surgery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 105 participants (estimated)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 16 Jan 2021 (actual)
- Primary completion
- 1 Sep 2021 (estimated)
- Study completion
- 10 Sep 2021 (estimated)
- First posted
- 15 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will be conducted to compare the efficacy and safety of ultrasound guided erector spinae block , ultrasound guided caudal block and conventional caudal block for pain management after pediatric hip surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Conventional caudal block | Active comparator | Procedure: Conventional caudal blockPatients of this group will receive the conventional method (blind technique without ultrasound) of caudal block |
| Ultrasound-guided caudal block | Experimental | Procedure: Ultrasound-guided caudal blockPatients of this group will receive caudal block using ultrasound. |
| Ultrasound guided erector spinae plane Block | Experimental | Procedure: Ultrasound guided erector spinae plane BlockPatients of this group will receive ultrasound guided erector spinae plane Block at the level of the transverse process of the second lumbar vertebrae(L2) . |
Who may qualify
- Ages
- 4 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Both sex
- ASA physical activity I, II
- Age 4-12 years
- Admitted for elective hip surgery.
Key exclusion criteria (8 listed)
- Parents refusal
- Children with severe systemic disease
- ASA III or IV
- Children with previous neurological or spinal anomaly, coagulation disorders
- History of premature birth
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Conventional caudal blockPatients of this group will receive (0.5ml/kg) (plain bupivacaine 0.25% injected in the caudal epidural space) by the conventional method (blind technique without ultrasound). | Procedure or surgery | Conventional caudal block |
| Ultrasound-guided caudal blockUsing ultrasound, patients of this group will receive (0.5ml/kg) (plain bupivacaine 0.25% injected in the caudal epidural space). | Procedure or surgery | Ultrasound-guided caudal block |
| Ultrasound guided erector spinae plane BlockUnder ultrasound guidance, patients of this group will receive (0.5ml/kg) (plain bupivacaine 0.25% injected beneath the erector spinae muscle sheath) at the level of the transverse process of the second lumbar vertebrae(L2). | Procedure or surgery | Ultrasound guided erector spinae plane Block |
Primary outcome
Degree of pain intensity
Time frame: First 24 hours postoperative
To evaluate the pain scores by (FLACC) scale. (FLACC) scale will be assessed after surgery over 24 hours where (0 = Relaxed and comfortable, 1-3 = Mild discomfort, 4-6 = Moderate pain ,7-10 = Severe discomfort /pain)
7 secondary outcomes
Changes in mean arterial blood pressure
Time frame: Intraoperative and first 24 hours postoperative
Changes in heart rate
Time frame: Intraoperative and first 24 hours postoperative
Amount of Analgesic required in the first day after surgery
Time frame: First 24 hours postoperative
Time to first rescue analgesic demand after surgery.
Time frame: First 24 hours postoperative
Success rate of block
Time frame: Intraoperative duration
Duration of performing the block
Time frame: Intraoperative duration
Incidence of complications
Time frame: Intraoperative and first 24 hours postoperative
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2021.
- Individual participant dataSharing planned: Yes. Data will be available upon reasonable request
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Conventional caudal block, Ultrasound-guided caudal block and Ultrasound guided erector spinae plane Block in people with Conventional Caudal Block and Ultrasound Guided Caudal Block, run by Tanta University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Eman Hamdy Abu-Shanab, MSc (+201005518097, eman.hamdy@med.tanta.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Degree of pain intensity (time frame: First 24 hours postoperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jan 2021.